The FDA has approved modifications to Lundbeck's risk evaluation and mitigation strategy for Sabril, or vigabatrin, for pediatric seizures, according to the company. The FDA determined that some requirements were no longer needed to ensure a favorable risk/benefit ratio.
Researchers found that it may be unnecessary to require folic acid fortification of food products for new mothers and their babies. They said samples of food products voluntarily fortified with folic acid by food makers contain adequate amounts to reduce the risk of spina bifida and other birth defects.
The Medicare Physician Group Practice Demonstration, a project conducted by the CMS at 10 large provider practices across the U.S., reported better quality of care for chronic disease patients in practices that have implemented electronic health record systems. The Geisinger Clinic in Pennsylvania and the University of Michigan Family Practice Group were two practices that demonstrated improvements in at least 29 of the 32 quality measures monitored in the third year of the five-year project.